(12 days)
SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.
SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile.
SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.
The provided text does not contain information about acceptance criteria or a study proving device performance in the context of a diagnostic or AI-powered medical device. The documents are 510(k) notifications for two medical devices: the SMart™ Offset Stapes Piston Prosthesis and the SMart™ ISJ Prosthesis.
These notifications focus on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria through a clinical study or AI performance evaluation. The substantial equivalence argument is based on similar intended use, comparable materials (with acknowledged differences whose biocompatibility is asserted), and similar design features.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study that proves the device meets them, as this kind of information is not present in the provided FDA 510(k) summary. The document does not describe:
- Acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy).
- A study (clinical or otherwise) designed to measure the device's performance against such criteria.
- Sample sizes for test or training sets, as it's not an AI/diagnostic device.
- Expert ground truth establishment, adjudications, or MRMC studies, as these relate to performance evaluation of diagnostic tools, which these prostheses are not.
- Standalone algorithm performance as there is no algorithm.
- Type of ground truth (pathology, outcomes data) as this relates to diagnostic accuracy.
- Training set sample size or how its ground truth was established, as this is irrelevant for a physical medical implant.
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.